EU
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices under the existing legal framework.
ANVISA
The new article provides further clarifications on the applicable regulatory requirements, paying special attention to the most important aspects.
ANVISA
The new article highlights certain specific aspects related to the regulatory status of personalised devices allowed for marketing and use in Brazil.
ANVISA
The new article covers the matters related to classification of personalised devices and provides additional clarifications in this respect.
EU
The final article of the cycle is dedicated to combination products and their specific regulatory nature.
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